T2 1825-1240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540199799), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER "GD" REPORTED TO ANSM THAT: "RIGHT LEG SWOLLEN, HARD TO THE TOUCH. REMAINS SWOLLEN FOR SEVERAL HOURS AFTER OBSERVATION, UNTIL LYING DOWN, EVEN THOUGH THE LEG WAS LEFT IN THE OPEN AIR WITHOUT RESTRAINT (NO SOCKS OR TIGHT CLOTHES). SHORTNESS OF BREATH AND FEELING OF TIREDNESS, HEADACHES (OCCIPITAL LOBE AREA AND FRONTAL LOBE AREA), VERY SLIGHT PRICKLING SENSATION IN THE HEART. THE SWOLLEN LEGS, I OBSERVED THEM FROM ON (B)(6) 2021, THAT'S WHAT MADE ME DECIDE TO FILL IN THESE FIELDS."

  Patient problems: Fatigue; Headache; Swelling/ Edema; Unspecified Heart Problem; Unspecified Respiratory Problem

  MAUDE report 12583904 ↗